A Pilot Study of ALTENS in Improving Dysphagia Induced by IMRT for Head and Neck Cancers

NCT01697891 | Unknown Phase 1

• 1 other identifier: MU12-530
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation completion, can improve radiation-induced dysphagia and associated symptoms in head and neck cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis. Primary study objective: To evaluate the effectiveness of ALTENS in relieving radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this primary study endpoint.

Conditions

Head and Neck Cancer; Dysphagia

Keywords

Radiation Treatment; Head and Neck Cancer; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline

  EAT-10 is a self-administered questionnaire for subjective assessment of dysphagia. It consists of 10 items and each item is scored using a 5-point Likert scale. The higher the point, the more severe the problem being scored. Normative data suggested that a total score of 3 or higher is abnormal.

  3 months after treatment completion

Secondary Outcomes (1)

• Change in M. D. Anderson dysphagia inventory from baseline

  3 months after treatment completion

Study Arms (1)

ALTENS

EXPERIMENTAL

Patients in this arm will be treated with Acupuncture-like Transcutaneous Electrical Nerve Stimulation using Codetron (Codetron ALTENS)

Device: Codetron ALTENS

Interventions

Codetron ALTENS DEVICE

ALTENS stimulation of a set of selected acupuncture points for 20 minutes in each treatment. Two treatments per week for a total of 12 treatments to be delivered within 8 weeks.

ALTENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• present with dysphagia symptoms
• with no evidence of residue cancer
• are within 3 months (but past 1 month) after treatment completion
• show positive dysphagia (EAT-10 score of \> 3) and/ or aspiration on barium swallow study
• are over 18 years old
• are able to read and write fluent English
• can give informed consent

You may not qualify if:

• have unstable heart disease
• have infectious disease transmissible by blood or body fluid, including hepatitis and HIV
• have skin disease at site of study acupuncture points that prevents the application of electrodes

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Raimond Wong, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Oncology

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 2, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 2, 2012

Record last verified: 2012-10

Locations

CA (1)